12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Erchonia Zerona® VZ8
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M™ Unitek™ Victory Series™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221017994·Victory Series(TM) Low Profile Bracket MBT(TM) ...
GPC Intraheal Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
Sterile Hypodermic Syringes for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
BD INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 18, 2025
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
INTRALASE PATIENT INTERFACE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·September 1, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 23, 2013
BD INTIMA-II
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·August 11, 2025
BD INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·June 30, 2025
BD INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 31, 2025
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014